The WHO Good Reliance Practices (Annex 10) provide essential principles and considerations for regulatory reliance implementation. However, it is not clear how well agencies have been incorporating these principles into their reliance mechanisms. To enable continuous improvement and alignment with good practice, a mechanism for systematic monitoring of reliance pathways is needed.
A CIRS project initially focusing on Latin America is assessing the extent to which current reliance practices reflect good practice, as stated by WHO Annex 10.
The project aims to:
- Assess the implementation of reliance in 10 selected countries in Latin America
- Identify barriers and enablers for effective implementation of reliance
- Identify areas for improvement and alignment compared to Good Reliance Practices
- Foster collaboration and knowledge exchange within the region to build capacity, enhance regulatory efficiency and support continuous improvement.
Members of our Regulatory team will be travelling to Brasilia, Brazil, next week to share key findings from the project at the FIFARMA Annual Summit.
The reliance monitoring project represents a significant step toward systematic global reliance assessment, identifying current practices, barriers, and enablers for improvement whilst determining alignment with WHO Good Reliance Practices. Success in Latin America will inform global expansion, enhancing understanding of effective reliance implementation and supporting evidence-based improvements in regulatory cooperation worldwide.
